Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by December 13, 2002.
Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Stuart Shapiro, Desk Officer for FDA.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.End Further Info End Preamble Start Supplemental Information
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Medical Device Recall Authority—21 CFR Part 810 (OMB Control Number 0910-0432)—Extension
This collection implements medical device recall authority provisions under section 518(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360h) and part 810 (21 CFR part 810). Section 518(e) of the act gives FDA the authority to issue an order requiring the appropriate person, including manufacturers, importers, distributors, and retailers of a device to immediately cease distribution of such device, to immediately notify health professionals and device-user facilities of the order, and to instruct such professionals and facilities to cease use of such device, if FDA finds that there is reasonable probability that the device intended for human use would cause serious adverse health consequences or death.
Section 518(e) of the act sets out a three-step procedure for issuance of a mandatory device recall order. First, if there is a reasonable probability that a device intended for human use would cause serious, adverse health consequences or death, FDA may issue a cease distribution and notification order requiring the appropriate person to immediately: (a) Cease distribution of the device, (b) notify health professionals and device user facilities of the order, and (c) instruct those professionals and facilities to cease use of the device. Second, FDA will provide the person named in the cease distribution and notification order with the opportunity for an informal hearing on whether the order should be modified, vacated, or amended to require a mandatory recall of the device. Third, after providing the opportunity for an informal hearing, FDA may issue a mandatory recall order if the agency determines that such an order is necessary.
The information collected under the recall authority will be used by FDA to ensure that all devices entering the market are safe and effective, to accurately and immediately detect serious problems with medical devices, and to remove dangerous and defective devices from the market.
The respondents to this proposed collection of information are manufacturers, importers, distributors, and retailers of medical devices.
FDA estimates the burden of this collection of information as follows:
|21 CFR Section||No. of Respondents||Annual Frequency per Response||Total Annual Responses||Hours per Response||Total Hours|
|810.12(a) through (b)||1||1||1||8||8|
|810.15(a) through (d)||2||1||2||16||32|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
Explanation of Report Burden Estimate:
The following estimates are based on FDA's experience with voluntary recalls under 21 CFR part 7. FDA expects no more than two mandatory recalls per year, as most recalls are done voluntarily.
Section 810.10(d)—FDA estimates that it will take approximately 8 hours for the person named in a cease distribution and notification order to gather and submit the information required by this section. The total annual burden is 16 hours.
Section 810.11(a)—Based on its experience in similar situations, FDA expects that there will be only one request for a regulatory hearing per year and that it will take approximately one staff day (8 hours) to prepare this request.Start Printed Page 68877
Section 810.12(a) through (b)—Based on its experience in similar situations, FDA expects that there will be only one written request for a review of cease distribution and notification order per year and that it will take approximately one staff day (8 hours) to prepare this request.
Section 810.14—Based on its experience with voluntary recalls, FDA estimates that it will take approximately two staff days (16 hours) to develop a strategy for complying with this order.
Section 810.15(a) through (d)—Based on its experience with voluntary recalls, FDA estimates that it will take approximately two staff days (16 hours) to notify each health professional, user facility, or individual of the order.
Section 810.15(e)—Based on its experience with voluntary recalls, FDA estimates that there will be approximately five consignees per recall (10 per year) who will be required to notify their consignees of the order. FDA estimates it will take them about 1 hour to do so.
Section 810.16—FDA estimates that it would take no more than one staff week (40 hours) to assemble and prepare a written status report required by a recall (§ 810.16). The status reports are prepared by manufacturers 6 to 12 times each year. Therefore, each manufacturer would spend no more than 480 hours each year preparing status reports (40 x 12). If there were two FDA invoked recalls each year, the total burden hours would be estimated at 960 hours each year (480 x 2).
Section 810.17—Based on its experience with similar procedures, FDA estimates it would take one staff day (8 hours) to draft a written request for termination of a cease distribution and notification or mandatory recall order.Start Signature
Dated: November 5, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-28713 Filed 11-12-02; 8:45 am]
BILLING CODE 4160-01-S